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Cardiogenesis submits an IDE for its PHOENIX System

Cardiogenesis Corporation, today announced that it has submitted an IDE (Investigational Device Exemption) to the Food and Drug Administration to initiate a safety and feasibility trial for its PHOENIX System in patients with refractory angina. The PHOENIX handpiece is the first device specifically designed to allow physician-directed tissue stimulation and injections of biologic or pharmacologic agents to pre-determined areas of myocardium.

4 Jan 2010

Bausch & Lomb launches Crystalens AO intraocular lens

Bausch & Lomb today announced that it is launching the Crystalens® AO, the first aberration-free accommodating intraocular lens (IOL) with aspheric optics to cataract surgeons worldwide.

4 Jan 2010

Cepheid granted EUA for Xpert Flu A Panel test

Cepheid today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Xpert® Flu A Panel test.

4 Jan 2010

GeckoSystems to resume in home personal companion robot trials after Holidays

GeckoSystems Intl. Corp. (http://www.geckosystems.com/) announced today that they have resumed their in home personal companion robot trials for elder care after pausing during the Holidays.

4 Jan 2010

Continua Health Alliance to showcase new end-to-end connected health solution at 2010 Consumer Electronics Show

Continua Health Alliance today announced the first end-to-end connected health solution based on the Continua architecture. Continua, the non-profit, open industry alliance of more than 220 leading healthcare and technology organizations, heralded the development as a significant milestone in the group’s mission to establish an ecosystem of interoperable personal connected health solutions.

4 Jan 2010

Cardima receives Shonin approval from the Japanese MHLW to market PATHFINDER catheters

Cardima, Inc., a medical device company focused on the diagnosis and treatment of atrial fibrillation (AF), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to re-enter the Japanese market with its family of guidewire-based, multi-electrode PATHFINDER® diagnostic mapping catheters.

4 Jan 2010

WDI utilizes DXA analysis for fitness and weight management programs

Women's Digital Imaging of Ridgewood (WDI), has begun using Dual Energy X-ray Absorptiometry (DXA), a technology developed to screen for osteoporosis (bone loss), to measure body fat in patients who want a more accurate method of establishing goals and measuring results for weight management and fitness programs.

4 Jan 2010

Study shows significant benefit of hyperbaric oxygen therapy to improve brain metabolism

A 5-year study of patients with severe traumatic brain injury conducted at Hennepin County Medical Center in Minneapolis shows significant benefit of hyperbaric oxygen therapy to improve brain metabolism and its ability to recover from injury.

4 Jan 2010

EGS receives U.S. patent covering its SerosaFuse fastener and “over the wire” delivery system

EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced that the U.S. Patent and Trademark Office has issued a key patent covering its SerosaFuse fastener and “over the wire” delivery system.

4 Jan 2010

Simulated Environment Concepts completes negotiations with Zen & O to manufacture 250 SpaCapsules

Simulated Environment Concepts, Inc., makers of the high pressurized dry water massage and relaxation station SpaCapsule, announced that it has completed negotiations with the French company Zen & O, securing a multi-million dollar deal to manufacture 250 SpaCapsules over the next four years.

4 Jan 2010

International Isotopes submits a license application for its uranium de-conversion and fluorine extraction project

International Isotopes Inc. announces it has submitted its license application to the U. S. Nuclear Regulatory Commission (NRC) for its depleted uranium de-conversion and fluorine extraction processing facility.

3 Jan 2010

TENS therapy is not effective against chronic low-back pain

A new guideline issued by the American Academy of Neurology finds that transcutaneous electric nerve stimulation (TENS), a widely used pain therapy involving a portable device, is not recommended to treat chronic low-back pain that has persisted for three months or longer because research shows it is not effective.

31 Dec 2009

CMS and ONC issue regulations to implement widespread adoption of EHR incentive programs

The U.S. Department of Health and Human Services’ Centers for Medicare & Medicare Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) encourage public comment on two regulations issued today that lay a foundation for improving quality, efficiency and safety through meaningful use of certified electronic health record (EHR) technology.

31 Dec 2009

New chromosomal screening strategy shows promise in PGS

A new strategy that researchers believe provides a more comprehensive screening of the entire chromosomal makeup of an embryo shows tremendous promise in the field of preimplantation genetic screening (PGS) according to a study published in the December issue of Fertility and Sterility.

31 Dec 2009

Majority of physicians think EMRs can compromise patients' safety

Press Ganey Associates' 2009 Hospital Pulse Report: Physician Perspectives on American Hospitals found physicians' satisfaction with electronic medical records (EMRs) is decreasing. Many physicians actually consider this increasingly common technology to be time-consuming and fear that it may compromise patient safety.

31 Dec 2009

Sonomax Hearing Healthcare completes milestone development of custom-fitted earpieces

Sonomax Hearing Healthcare Inc. announces that it has completed Phase V, its final milestone in the development of its off-the-shelf, self-fitting, custom earpieces. The company is now in a position to roll out its prototype V4(R), establishing Sonomax as the world's only producer of instant self-fitting custom earpieces.

31 Dec 2009

Solos Endoscopy looks forward to strengthen its business in 2010

Solos Endoscopy, Inc. is pleased to announce that the Company looks forward to a prosperous 2010, following a solid year in 2009, due in great part to its MammoView(TM) instrument line.

31 Dec 2009

St.Vincent Indianapolis Hospital renews campus-wide contract for Masimo SET pulse oximetry technology

Masimo, the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that St.Vincent Indianapolis Hospital has renewed its campus-wide contract for Masimo SET pulse oximetry technology.

31 Dec 2009

FDA approves distribution of ZOLL E Series Monitor/Defibrillator

ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new model of the ZOLL E Series® Monitor/Defibrillator with carbon monoxide (CO) measurement. The product is immediately available for shipment.

31 Dec 2009

Researchers study the effectiveness of colonoscopy in preventing colorectal cancer

The prevalence of left-sided advanced colorectal neoplasms was lower in participants in a community setting, but not right-sided advanced neoplams, who had received a colonoscopy in the preceding 10 years, according to a new study published online December 30 in the Journal of the National Cancer Institute.

31 Dec 2009

Device / Technology News

Cardiogenesis submits an IDE for its PHOENIX System

Bausch & Lomb launches Crystalens AO intraocular lens

Cepheid granted EUA for Xpert Flu A Panel test

GeckoSystems to resume in home personal companion robot trials after Holidays

Continua Health Alliance to showcase new end-to-end connected health solution at 2010 Consumer Electronics Show

Cardima receives Shonin approval from the Japanese MHLW to market PATHFINDER catheters

WDI utilizes DXA analysis for fitness and weight management programs

Study shows significant benefit of hyperbaric oxygen therapy to improve brain metabolism

EGS receives U.S. patent covering its SerosaFuse fastener and “over the wire” delivery system

Simulated Environment Concepts completes negotiations with Zen & O to manufacture 250 SpaCapsules

International Isotopes submits a license application for its uranium de-conversion and fluorine extraction project

TENS therapy is not effective against chronic low-back pain

CMS and ONC issue regulations to implement widespread adoption of EHR incentive programs

New chromosomal screening strategy shows promise in PGS

Majority of physicians think EMRs can compromise patients' safety

Sonomax Hearing Healthcare completes milestone development of custom-fitted earpieces

Solos Endoscopy looks forward to strengthen its business in 2010

St.Vincent Indianapolis Hospital renews campus-wide contract for Masimo SET pulse oximetry technology

FDA approves distribution of ZOLL E Series Monitor/Defibrillator

Researchers study the effectiveness of colonoscopy in preventing colorectal cancer

How industrial hygiene flow calibration supports defensible exposure data

How electrical engineering ensures accurate calibration and patient safety

The importance of ketones from a clinical and medical perspective

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